Sponsor-Dedicated CRA II working on Neurology trials in Nashville, TN.

- Responsible for monitoring all types of clinical trials; assures site/investigator adherence to Good Clinical Practice, investigator integrity, and compliance with all study procedures- Primary responsibility is for site management and performance, including documentation. Site management activities include all in-house and on-site monitoring for all visit types.

- Worked with the Candidate to build out policy positions, platform, and overall messaging forthe campaign.- Collaboratively designed, developed, and produced campaign branding and imagery- Consulted on campaign expenses such as literature, signs, campaign paraphernalia, andstrategic advertisement purchases, etc.- Oversaw on-the-ground/digital voter outreach plans using accessible voter data anddatabases.- Used acquired data and collaborated with the Candidate, planned out the district strategy,and targeted appropriate voters/precincts.areas, etc.- Collaborated with Candidate on the campaign calendar and worked with the campaign teamto build out a tentative campaign calendar/schedule leading to Election Day.- Oversaw fundraising efforts, i.e. donor research, list building, call time management,prospect follow-up, event planning, and digital fundraising efforts, etc. to maximizecandidate and campaign potential.

Identify, select, initiate, and close-out appropriate investigational sites for clinical studies. To monitor those sites in order to ensure that studies are carried out according to the study protocol and in accordance with ICON SOPs/WPs, applicable regulations, and the principles of ICH-GCP.

- Served as the primary unblinded CRA for 22 sites- Assisted specifically in study close-out for 8 sites- Engaged in identification, selection, initiation, and close-out of appropriate investigational sites for clinical studies- Communicated with sites on a regular basis to resolve queries, collect missing documentation, complete action items, and maintain data entry timeliness- Completed monitoring visits sites both on-site and remotely in order to ensure that studies are carried out according to protocol- Contributed to the culture of process improvement with a focus on streamlining our processes, adding value to our business, and meeting client needs- Recognized, exemplified, and adhered to ICON’s values, which center around a commitment to people, clients, and performance

- Served as the primary in-house contact for sites and investigators at 60+ sites in the United States and Canada- Maintained timelines and ensured accuracy and completeness of data entered into ICON systems- Conducted and completed remote site management activities, with support as needed, according to applicable SOPS and the Study Monitoring Plan.- Contacted clinical sites for specific requests (e.g. enrollment updates, missing documentation, data entry timeliness, data query follow-up, CDA finding follow-up, and action Item resolution or other sponsor specific CRA tasks).- Maintained a professional interpersonal relationship with study team, sites, and Sponsors- Regularly attended project-specific and departmental meetings- Maintained Sponsor and patient confidentiality- Other duties as assigned

- Provided general administrative support to the Clinical Operations Department and assistance to Project Manager(s) and Project Director(s)- Assisted Clinical Operations teams in completion of all required tasks to meet departmental and project goals- Received training in ICH-GCP, appropriate regulations, relevant ICON SOPs and ICON internal tracking systems- Assisted project teams with study specific documentation and guidelines as appropriate- Organized and maintained clinical study documentation, including preparation for internal/external audits, final reconciliation, and archival- Attended project team meetings and generated meeting minutes- Other duties as assigned

- Provided supervision for youth shelter residents- Coordinated and supervised activities for residents when appropriate or assigned- Provided intake and assessment services to youth and families referred to the shelter program- Provided group services when appropriate or assigned- Facilitated the referral process for potential clients- Documented client interaction in a consistent and ethical manner- Provided liaison and referral services with appropriate mental health centers, courts, physicians, school systems, Department of Children’s Services and others as needed- Transported clients as needed

- Completed over 200 internship hours over the course of the semester- Participated in weekly supervision with clinical counselor- Interacted one-on-one with 13-17 year olds coming from a variety of backgrounds (homelessness, runaway, environments of abuse, etc.)- Completed referrals, youth interviews, and intakes into the emergency shelter

- Worked alongside a team of mental health professionals to make plans and find solutions for the clientele base of children aged 7-13- Provided emotional support and training on coping skills to at-risk children and teenagers- Produced detailed reports of activities for efficient organization of record